First, the FDA did not say outright no to the first of the two phase 2 trials Dendreon tried to push across the line. The ADCOM, including Pazdur, said yes, 13 to 4, but the FDA, seeing that they had another phase 2 that was going read out in a year, decided to wait for those results- much to the chagrin of us Dendreonites. The second trial was positive and the results have been confirmed by a second large study called PROTECT that ran from 2011 to 2017. So for years the market was pricing Provenge to fail but the market was wrong. Dendreon failed spectacularly but that’s a bigger story.
Regarding the stock price, it varied between $3 and $8 a share for years before approval. Most Dendreonites like me had an average share price around $5 so those of us that sold at the top got a 10 bagger. I sold half and wish I had sold all of it, but I learned valuable lessons. I believe Northwest Bio did too.
Why do I believe that? Because in 2010 NWBio was still headquartered in the northwest, in Bothell, Washington and was led by interim CEO Larry Kenyon. The move to Maryland and naming of Powers as CEO occurred the following year in 2011. The Seattle biotech scene was tight knit. LP has commented on learning from Dendreon’s mistakes.
Someone posted on here that manufacturing was the big issue with DNDN. It was, at best, the #3 issue. The #1 issue by far was pricing and reimbursement, along with skepticism about immunotherapy in general. Keep in mind Provenge was the first ever immunotherapy approved by the FDA; since then over 50 immunotherapy drugs have been approved by the FDA.
For Northwest Bio, how pricing reimbursement is handled is still to be determined - hopefully they learned some lessons.
The other big factor in DNDN’s demise was competition in the mCRPC space. NWBO has a massive advantage here. Even when DNDN hit their high watermark of about $6 billion market cap was well known that their drug was, at best, the third best treatment of new treatments coming onto the market - Zytiga and Xtandi were both looming and quickly grabbed market share.
Patience and patients,
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